Hypothesis / aims of study
Genitourinary syndrome of menopause (GSM) commonly affects postmenopausal women with nearly 50% of postmenopausal women reporting at least one symptom related to vaginal atrophy. These wide-ranging symptoms include pain during sexual intercourse, lack of lubrication, vaginal dryness, vaginal itching, dysuria, and recurrent urinary tract infections. Traditionally, treatment for GSM included nonhormonal vaginal lubricants and moisturizers or locally applied estrogen cream. In recent years, vaginal laser therapy has been introduced as a potential new treatment option for women with GSM and sexual dysfunction. Prior studies have presented promising data with regards to improvements in symptoms of GSM. The aim of the current study was to assess the short-term and long-term effects of the fractional CO2 laser system in treating postmenopausal women with clinical symptoms of genitourinary syndrome of menopause.
Study design, materials and methods
This prospective study included sexually active postmenopausal women who presented to the clinic with symptoms of GSM including vaginal dryness, itching, burning, dysuria, or dyspareunia between September 2019 and February 2021. Three treatment visits were scheduled with intervals of four weeks between each visit. The treatment of the vaginal canal was performed using the fractional CO2 laser system (SmartXide2V2LR, MonaLisa Touch; DEKA, Florence, Italy). Patients were asked to complete questionnaires before the start of treatment, one month following the third treatment, at six months follow-up, and at 1-year follow-up either during in-person clinic visits or by telephone follow-up. Informed written consent was obtained from all study subjects. GSM symptom severity was self-evaluated by study participants on a 10cm visual analogue scale (VAS). The women completed a 19-item Mandarin version of the Female Sexual Function Index (FSFI), a validated standard questionnaire frequently utilized for assessing female sexual function and quality of life. This questionnaire was designed to assess sexual function in women with a specific focus on sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. All statistical analyses were performed using SAS software version 9.4 (SAS Institute, Inc., Cary NC, USA). The changes from baseline in the assessment of GSM symptoms and FSFI scores were evaluated using repeated measures analysis of variance models. Statistical significance was set at p<0.05.
Results
Twenty-eight postmenopausal women who were sexually active and treated with fractional CO2 laser completed the protocol of three laser treatments and a one-year follow-up period. The mean age of the women was 55.37±4.36 years (±SD), and the mean number of years since menopause was 6.56±5.05 years. VAS scoring of GSM symptoms is presented in Table 1. GSM symptoms such as vaginal itching, vaginal burning, dyspareunia, dysuria, and vaginal dryness were significantly improved at one month following the completion of three laser treatments when compared with baseline. This statistically significant improvement was maintained at both six months and one-year follow-up visits. The short-term and long-term effects of fractional CO2 laser treatment on GSM symptoms were also assessed via the FSFI questionnaire. These results are presented in Table 2. The mean baseline score of FSFI (±SD) was 10.44±1.53. Following three laser treatments, the one-month follow-up showed a statistically significant increase in total FSFI score to 19.12±2.82, and at the six- and twelve-month follow-up visits, the total FSFI remained significantly higher than at baseline with total scores of 20.16±4.14 and 20.07±4.12, respectively. At one-month follow-up, the FSFI domains of desire (3.44±0.32), arousal (3.28±0.62), orgasm (3.44±0.59), satisfaction (3.70±0.66), and pain (3.47±0.61) showed significant improvements when compared with baseline. Only the lubrication domain did not show a statistically significant improvement when compared with baseline at the one-month follow-up. However, at the six-month follow-up, all six FSFI domains showed significant improvement when compared with follow-up and this improvement continued to be observed at the one-year follow-up.
Interpretation of results
Vaginal laser therapy has been reported to be a safe, effective, and noninvasive procedure that can restore vaginal health and improve sexual function. Currently, there are radiofrequency devices that produce tissue contraction as heat develops, CO2 lasers which fractionally ablate the tissue and cause contraction with subsequent tissue remodeling, and Er:YAG lasers which produce wound contraction secondary to tissue heating. Studies have found that laser therapy is able to stimulate angiogenesis, increase fibroblast activity and induce collagen formation without any associated ablative or thermal damage to the vagina. Specifically, fractional CO2 laser therapies have been shown to improve blood flow in vaginal tissues which assists in restoring elasticity and moisture of the vaginal canal. Furthermore, previous studies that have investigated the histological changes in vaginal epithelium found that post-fractional CO2 laser treatments, there was an increased amount of collagen deposits and elastic fibers, a thicker epithelium, and increased submucosal vascularity. The present study evaluated the long-term efficacy of fractional CO2 laser treatment in postmenopausal women with symptoms of GSM. The results presented in this study showed statistically significant improvement in the assessment of GSM symptoms and sexual function by VAS and the FSFI questionnaire. Significant improvements in GSM symptoms of dyspareunia, dysuria, vaginal itching, vaginal burning, and vaginal dryness were seen at one-month follow-up after three laser treatments and these improvements were sustained up to one-year follow-up. Of the FSFI domains, only lubrication did not show a statistically significant improvement at the one-month follow-up. However, at the six-month follow-up, FSFI lubrication domain scores showed a statistically significant improvement when compared with baseline and this improvement was sustained at the one-year follow-up. All other FSFI domains including arousal, orgasm, pain, satisfaction, and desire showed a statistically significant improvement over baseline at the one-month follow-up and these effects continued to be observed at the one-year follow-up. Previous studies showed improvement in the FSFI at shorter follow-up periods of up to six months. Of note, in the current study, a significant improvement in GSM symptoms was able to be maintained up to one year after completion of laser treatments.
Concluding message
In conclusion, fractional CO2 vaginal laser treatment is a promising, non-pharmacological, minimally invasive treatment option for postmenopausal women experiencing genitourinary syndrome of menopause. Significant improvements in sexual function, dyspareunia, dysuria, vaginal burning, vaginal itching, and vaginal dryness were noted at one-month follow-up after the three laser treatments and were able to be sustained for up to one-year post-treatment.